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Quiz 2025 Perfect ACRP-CP: ACRP Certified Professional Exam Dumps Guide

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ACRP Certified Professional Exam Sample Questions (Q112-Q117):

NEW QUESTION # 112
SAEs must be reported immediately by the site to the:

A. DSMB/IDMC.
B. Sponsor.
C. Regulatory agency.
D. IRB/IEC.

Answer: B

Explanation:
Serious Adverse Events (SAEs) must be reported immediately to the sponsor. The sponsor then assesses the severity, causality, and potential impact on the study and decides whether further reporting to regulatory authorities and IRB/IEC is required. Immediate reporting ensures that appropriate actions are taken to safeguard participant safety.
GCP guidelines specify that the site must notify the sponsor immediately about any SAE to ensure timely safety assessment and reporting.
"Sites must report all serious adverse events immediately to the sponsor, who will then determine the appropriate regulatory and ethical reporting requirements." Objectives:
* Ensure rapid reporting of serious adverse events.
* Maintain safety monitoring during the trial.

NEW QUESTION # 113
The IRB/IEC has decided to not approve a clinical trial. Who must they notify in writing?

A. PI
B. CRC
C. Sponsor
D. Regulatory Agency

Answer: A

Explanation:
When the IRB/IEC decides not to approve a clinical trial, they must notify the Principal Investigator (PI) in writing. This communication ensures that the PI is formally informed of the decision and cantake appropriate actions, such as revising the protocol or addressing the reasons for disapproval.
According to GCP guidelines, the IRB/IEC must communicate any decision regarding the approval status of a study directly to the PI, as the PI is responsible for the conduct of the trial.
"The IRB/IEC should promptly notify the investigator in writing of its decision to approve or disapprove the proposed research activity." Objectives:
* Maintain clear communication between the IRB/IEC and the investigator.
* Ensure timely notification of decisions affecting the study.

NEW QUESTION # 114
A study has been closed for two years after the last approval of a marketing application of an IP. No additional applications are pending and there are no further developments planned for the IP. Which of the following statements is the BEST course of action regarding the destruction of the essential documents?

A. The site should retain the essential documents longer to meet the regulatory requirements.
B. The site should contact the sponsor and receive written notification prior to destruction that the essential documents are no longer needed.
C. The site should contact the sponsor and receive verbal notification they are no longer needed andthe essential documents may be destroyed.
D. The site may proceed with the destruction of the essential documents.

Answer: B

Explanation:
Before destroying any essential documents, the site must obtain written confirmation from the sponsor that these documents are no longer needed. This ensures compliance with regulatory requirements, as some countries may require document retention for longer periods, even after study closure and marketing approval.
GCP guidelines state that the sponsor must confirm in writing that essential documents can be destroyed after ensuring compliance with local regulations.
"Before destroying essential documents, written confirmation from the sponsor is required to ensure compliance with regulatory retention policies." Objectives:
* Maintain compliance with document retention regulations.
* Prevent premature destruction of essential trial records.

NEW QUESTION # 115
A study to determine the effective dose and regimen of a new IP for the treatment of hypothyroidism is considered to be:

A. Phase I
B. Phase III
C. Phase II
D. Phase IV

Answer: C

Explanation:
A Phase II clinical trial is typically conducted to evaluate the efficacy of a drug, determine the optimal dosing regimen, and further assess its safety profile. Since the objective is to establish the effective dose and regimen for hypothyroidism treatment, this clearly falls under Phase II.
GCP guidelines categorize Phase II trials as those aimed at determining efficacy and optimal dosing of investigational products.
"Phase II trials focus on determining the therapeutic efficacy, optimal dosage, and further evaluating the safety of the investigational product." Objectives:
* Identify effective dosing regimens.
* Evaluate therapeutic efficacy for targeted conditions.

NEW QUESTION # 116
Source data/documentation should be:

A. Attributable, legible, correct, original, accurate, and clear.
B. Attributable, legible, contemporaneous, original, accurate, and complete.
C. Attributable, legible, contemporaneous, original, accurate, and clear.
D. Attributable, legible, correct, original, accurate, and complete.

Answer: B

Explanation:
Source data/documentation in clinical trials must meet the ALCOA-C standard: Attributable, Legible, Contemporaneous, Original, Accurate, and Complete. This ensures that data is credible, traceable to the source, and maintains integrity throughout the study. These attributes are essential for maintaining high- quality, reliable, and verifiable clinical trial records.
GCP guidelines mandate that source documentation should adhere to the ALCOA-C principles to maintain data integrity and reliability.
"Source data must be attributable, legible, contemporaneous, original, accurate, and complete to meet quality and compliance standards." Objectives:
* Maintain data integrity and reliability.
* Adhere to best practices in clinical documentation.

NEW QUESTION # 117
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